The FOSHU approval system, though faulty, should be made mandatory for all
functional foods.

The FOSHU system represents an attempt to establish a formal approval system for
functional foods that contain specific ingredients proven to have beneficial health effects. However,
the sales of non-FOSHU-approved health foods greatly exceeds that of FOSHU-approved products.
Moreover, the former category contains numerous products of dubious benefit. The system should thus be made mandatory to achieve its objectives of improving the health of the Japanese people
and eliminating misleading health claims.

The fat, cholesterol, sodium and sugar content of FOSHU-approved foods should be
limited.

The MHW should not approve foods with added functional ingredients that contain
significant amounts of fat, saturated fat, cholesterol, sodium, or added sugars. Because good health
depends on a diet that is low in such nutrients, it makes little sense to encourage consumption of
foods high in those nutrients by allowing manufacturers to promote such foods on the basis of
added functional ingredients.

Standards for FOSHU approvals should be tightened.

The MHW should upgrade requirements for the type of scientific evidence that must be
submitted to obtain FOSHU approval. While double-blind clinical trials need not be required in all
cases, rigorous scientific testing should be an element of FOSHU approval. FOSHU approvals
should be granted only in cases where there is significant agreement within the scientific
community regarding the benefit of a particular ingredient.

Consumption of conventional foods should be encouraged.

In addition to facilitating the promotion of FOSHU foods, the MHW should encourage
consumers to consume a diet rich in healthful conventional foods, especially fruits, vegetables, and
fish. There is no question that such diets can help consumers maintain and improve their health and
form the basis for sound nutrition. In many cases, there may be no need for consumers to spend
money on functional foods with added ingredients. Sound nutrition based on conventional dietary changes should serve as the foundation of the Ministry's efforts to reduce the incidence of chronic
disease.

In conclusion, some might argue that implementing such recommendations could discourage
the development and marketing of functional foods. However, the market for functional foods in
Japan is strong.(47) It is likely that companies would not abandon that market even if confronted with
mandatory regulatory requirements aimed at protecting the public. Rather than discouraging the
development of functional foods, such requirements would channel the energies of companies into
producing products that provide bona fide health benefits and that are accompanied by scientifically
valid health claims. The marketing of such products would increase the legitimacy of functional
foods and help fuel a demand for such products. Thus, such reforms will benefit both the consumer
and the food industry.